BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10188968 · Received June 24, 2020

    Report

    Report Number
    3013756811-2020-65938
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 24, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. SUBSEQUENTLY, THE PUMP BATTERY FULLY DEPLETED AND THE PUMP SHUT OFF. THE PUMP WAS ABLE TO BE SUCCESSFULLY CHARGED AFTER BEING POWERED BACK ON. ADDITIONALLY, THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. REPORTEDLY, THE CUSTOMER CORRECTED THE TIME TO RESOLVE THE ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 112-127(MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656297 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR